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Meta-Analysis
. 2020 Apr 7;4(4):CD012946.
doi: 10.1002/14651858.CD012946.pub2.

Laser-assisted in-situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism

Nicolás Kahuam-López  1   2 , Alejandro Navas  2 , Carlos Castillo-Salgado  3 , Enrique O Graue-Hernandez  2 , Aida Jimenez-Corona  4 , Antonio Ibarra  1
Affiliations
Meta-Analysis

Laser-assisted in-situ keratomileusis (LASIK) with a mechanical microkeratome compared to LASIK with a femtosecond laser for LASIK in adults with myopia or myopic astigmatism

Nicolás Kahuam-López et al. Cochrane Database Syst Rev. .

Abstract

Background: Laser-assisted in-situ keratomileusis (LASIK) is a surgical procedure that corrects refractive errors. This technique creates a flap of the outermost parts of the cornea (epithelium, bowman layer, and anterior stroma) to expose the middle part of the cornea (stromal bed) and reshape it with excimer laser using photoablation. The flaps can be created by a mechanical microkeratome or a femtosecond laser.

Objectives: To compare the effectiveness and safety of mechanical microkeratome versus femtosecond laser in LASIK for adults with myopia.

Search methods: We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2019, Issue 2); Ovid MEDLINE; Embase; PubMed; LILACS; ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP). We used no date or language restrictions. We searched the reference lists of included trials. We searched the electronic databases on 22 February 2019.

Selection criteria: We included randomized controlled trials (RCTs) of LASIK with a mechanical microkeratome compared to a femtosecond laser in people aged 18 years or older with more than 0.5 diopters of myopia or myopic astigmatism.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 16 records from 11 trials enrolling 943 adults (1691 eyes) with spherical or spherocylindrical myopia, who were suitable candidates for LASIK. Five hundred and forty-seven participants (824 eyes) received LASIK with a mechanical microkeratome and 588 participants (867 eyes) with a femtosecond laser. Each trial included between nine and 360 participants. In six trials, the same participants received both interventions. Overall, the trials were at an uncertain risk of bias for most domains. At 12 months, data from one trial (42 eyes) indicates no difference in the mean uncorrected visual acuity (logMAR scale) between LASIK with a mechanical microkeratome and LASIK with a femtosecond laser (mean difference (MD) -0.01, 95% confidence interval (CI) -0.06 to 0.04; low-certainty evidence). Similar findings were observed at 12 months after surgery, regarding participants achieving 0.5 diopters within target refraction (risk ratio (RR) 0.97, 95% CI 0.85 to 1.11; 1 trial, 79 eyes; low-certainty evidence) as well as mean spherical equivalent of the refractive error 12 months after surgery (MD 0.09, 95% CI -0.01 to 0.19; 3 trials, 168 eyes [92 participants]; low-certainty evidence). Based on data from three trials (134 eyes, 66 participants), mechanical microkeratome was associated with lower risk of diffuse lamellar keratitis compared with femtosecond laser (RR 0.27, 95% CI 0.10 to 0.78; low-certainty evidence). Thus, diffuse lamellar keratitis was a more common adverse event with femtosecond laser than with mechanical microkeratome, decreasing from an assumed rate of 209 per 1000 people in the femtosecond laser group to 56 per 1000 people in the mechanical microkeratome group. Data from one trial (183 eyes, 183 participants) indicates that dry eye as an adverse event may be more common with mechanical microkeratome than with femtosecond laser, increasing from an assumed rate of 80 per 1000 people in the femtosecond laser group to 457 per 1000 people in the mechanical microkeratome group (RR 5.74, 95% CI 2.92 to 11.29; low-certainty evidence). There was no evidence of a difference between the two groups for corneal haze (RR 0.33, 95% CI 0.01 to 7.96; 1 trial, 43 eyes) and epithelial ingrowth (RR 1.04, 95% CI 0.11 to 9.42; 2 trials, 102 eyes [50 participants]). The certainty of evidence for both outcomes was very low.

Authors' conclusions: Regarding the visual acuity outcomes, there may be no difference between LASIK with mechanical microkeratome and LASIK with femtosecond laser. Dry eye and diffuse lamellar keratitis are likely adverse events with mechanical microkeratome and femtosecond laser, respectively. The evidence is uncertain regarding corneal haze and epithelial ingrowth as adverse events of each intervention. The limited number of outcomes reported in the included trials, some with potentially significant risk of bias, makes it difficult to draw a firm conclusion regarding the effectiveness and safety of the interventions investigated in this review.

PubMed Disclaimer

Conflict of interest statement

NKL: none AN: none CCS: none EGH: none AJC: none AI: none

Figures

1
1
Trial flow diagram.
2
2
3
3
Risk of bias graph: review authors' judgments about each risk of bias item presented as percentages across all included trials
4
4
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.1 Mean uncorrected visual acuity after surgery [logMAR].
5
5
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.2 Proportion of eyes within ± 0.5 diopters of target refraction after surgery.
6
6
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.3 Mean spherical equivalent of the refractive error after surgery [diopters].
7
7
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.4 Corneal haze.
8
8
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.5 Dry eye.
9
9
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.6 Diffuse lamellar keratitis.
10
10
Forest plot of comparison: 1 LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, outcome: 1.7 Epithelial ingrowth.
1.1
1.1. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 1: Mean uncorrected visual acuity after surgery
1.2
1.2. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 2: Proportion of eyes within ± 0.5 diopters of target refraction after surgery
1.3
1.3. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 3: Mean spherical equivalent of the refractive error after surgery
1.4
1.4. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 4: Corneal haze
1.5
1.5. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 5: Dry eye
1.6
1.6. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 6: Diffuse lamellar keratitis
1.7
1.7. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 7: Epithelial ingrowth
1.8
1.8. Analysis
Comparison 1: LASIK with a mechanical microkeratome versus LASIK with a femtosecond laser, Outcome 8: Best corrected visual acuity after surgery
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References

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Li 2007 {published data only}
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Li 2010 {published data only}
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Li 2012 {published data only}
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Lian 2013 {published data only}
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McLaren 2007 {published data only}
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Montés Micó 2007b {published data only}
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Nau 2007 {published data only}
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NCT03193411 {published data only}
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NCT03484468 {published data only}
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NCT03597906 {published data only}
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Patel 2006 {published data only}
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Patel 2008 {published data only}
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Sonigo 2006 {published data only}
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Torky 2017 {published data only}
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von Jagow 2009 {published data only}
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Xia 2015 {published data only}
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Xie 2014 {published data only}
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Zhang 2011 {published data only}
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Zhang 2012 {published data only}
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Zhang 2013 {published data only}
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References to ongoing studies

PACTR201708002498199 {published data only}
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References to other published versions of this review

Kahuam‐López 2018
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